19 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OCCULTECH FECAL OCCULT BLOOD RAPID TEST
FDA 510(k)
FDA Class 2
·Hematology
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
FDA 510(k)
FDA Class 2
·Hematology
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·February 9, 2026
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·May 29, 2026
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·February 19, 2024
S5 DOUBLE HEAD PUMP
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
S5 CONTROL PANEL
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012
S5 CONTROL DISPLAY MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 14, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 13, 2008
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018